Device to Assist With Abdominal Access During Laparoscopic Surgery

NCT ID: NCT04392635

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2024-06-17

Brief Summary

The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.

Conditions

Laparoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TauTona Pneumoperitoneum Assist Device (TPAD)

Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed.

Group Type: EXPERIMENTAL

TauTona Pneumoperitoneum Assist Device (TPAD)

Intervention Type: DEVICE

The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.

Standard of Care (SOC)

Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: PROCEDURE

Standard of Care was used for Veress needle insertion.

Interventions

TauTona Pneumoperitoneum Assist Device (TPAD)

The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.

Intervention Type: DEVICE

Standard of Care (SOC)

Standard of Care was used for Veress needle insertion.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >/= 18
• Scheduled for laparoscopic surgery
• Able to understand and willing to sign a written informed consent form

Exclusion Criteria

• Age < 18
• Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
• Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
• Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
• Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TauTona Group

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R Korndorffer Jr, MD MHPE FACS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB-55013

Identifier Type: -

Identifier Source: org_study_id

NCT06361849

Identifier Type: -

Identifier Source: nct_alias